The device was returned for analysis.The reported mechanical jam and the reported activation failure were unable to be replicated in a testing environment due to the condition of the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the heavily calcified, heavily tortuous and 95% stenosed anatomy resulted in preventing the shaft lumens from moving freely; thus resulting in resistance with the slider and the difficulty deploying the stent.Manipulation of the device ultimately resulted in the noted hypotube separation contributing to the reported difficulties.There is no indication of a product quality issue with respect to design, manufacture or labeling.
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